Diagnostic Expertise
Full-service execution from protocol design through regulatory submission.
Sponsor Solutions
The only IVD-exclusive
partner for study execution.
Studybox partners with IVD sponsors as a strategic advisor and hands-on executor. We bring the diagnostic expertise, the right sites, and the operational infrastructure so your study moves faster, costs less, and gets done right.
Explore your options50+
Regulatory Clearances
30+
Years of Experience
100%
IVD Exclusive Focus
4
Active Regulatory Pathways
Why Studybox
Built exclusively for diagnostics.
Accelerated Timelines
Pre-established site relationships matched to your IUO profile.
Extensive Network
Site network spanning demographics, geographies, and clinical settings.
Simplified Complexities
Streamlined pathways under a single point of expertise.
Our process
From protocol to clearance.
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Protocol Design
We design or refine your protocol to meet FDA requirements and maximize site feasibility.
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Regulatory Strategy
We map the right regulatory pathway: 510(k), CLIA Waiver, EUA, or reproducibility.
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Site Selection
We match your IUO profile to sites across our established network for rapid activation.
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Study Execution
Enrollment, supply management, and site operations run under our direct oversight.
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Real-time Monitoring
Live dashboards, data review, QA, and deviation management throughout the study.
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Submission Ready
Study report, FDA response support, and clearance readiness delivered on time.
Our difference
We don't just run studies. We own outcomes.
Most CROs are built for pharma and adapted for diagnostics. We built Studybox from the ground up for IVD sponsors. That means faster site activation, fewer protocol amendments, and a team that speaks your language.
IVD Exclusive Focus
Every study we run is an in vitro diagnostic study. No diluted attention, no generalist assumptions.
End-to-end ownership
From protocol to FDA response, one team, one point of contact, zero handoffs.
Pre-qualified site network
Our sites are already trained on IVD protocols, so activation takes days, not months.
FAQ
Answers before you ask.
01 How quickly can you activate a study?
Because our sites are pre-qualified for IVD protocols, we can typically activate within 2 to 4 weeks of study initiation, compared to the 3 to 6 month industry average.
02 What study types do you support?
We support 510(k) analytical and clinical studies, CLIA Waiver studies, Emergency Use Authorization studies, De Novo submissions, and reproducibility and precision studies.
03 How do you handle protocol amendments?
Our regulatory team reviews protocols before study start to minimize amendment risk. When amendments do occur, we manage the FDA communication and site updates end-to-end.
04 Do you work with companies outside the US?
Yes. We work with international sponsors seeking FDA clearance for their IVD products, providing US-based site networks and regulatory expertise.
05 What is your typical study timeline?
Timeline depends on study complexity, enrollment requirements, and regulatory pathway. We provide detailed project timelines at study initiation and update them weekly throughout execution.
Start the conversation
Tell us about your program.
Tell us about your program and we will follow up within one business day.